Stable controlled release pharmaceutical compositions containing pravastatin
First Claim
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1. A controlled release dosage from comprising:
- (a) a core comprising pravastatin or a pharmaceutically acceptable salt, isomer, or derivative thereof; and
a buffering agent wherein the dosage form imparts a pH less than 9 when dissolved in 900 ml deionized water.
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Abstract
Stabilized sustained release pharmaceutical preparations containing a drug which is sensitive to a low pH environment, such as pravastatin are disclosed in which pravastatin degradation is prevented with a buffering agent. The basic excipient enhances storage stability.
20 Citations
19 Claims
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1. A controlled release dosage from comprising:
(a) a core comprising pravastatin or a pharmaceutically acceptable salt, isomer, or derivative thereof; and
a buffering agent wherein the dosage form imparts a pH less than 9 when dissolved in 900 ml deionized water. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 18, 19)
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14. A controlled release dosage form consisting essentially of:
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(a) a core with a pH of less than 9 consisting essentially of;
(i) 2-50 weight percent of pravastatin or a pharmaceutically acceptable salt, isomer, or derivitive thereof;
(ii) 30-95 weight percent of an osmagent;
(iii) 0.5-10 weight percent of a buffering agent;
(iv) 0-6 weight percent of a lubricant;
(b) a coating surrounding the core consisting essentially of;
(i) semipermeable film forming polymer and;
(ii) 0.5-20 weight percent of the coating of a plasticizer; and
(c) at least one exit means connecting the core with the exterior of the sustained release dosage form. - View Dependent Claims (15, 16, 17)
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Specification